DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 23-45 in the reply filed on 05/22/2026 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 23-27, 29, 31, 33, 35-36, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140142200 A1 (hereafter --Duan--).
Regarding Claim 23, Duan discloses a method for the production of a rehydrated crosslinked intrastromal corneal lenticule graft for use at least one treatment selected from the group consisting of Keratoconus treatment and vision correction (see paragraphs [0012] and [0041]), said corneal lenticule graft configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraphs [0019], [0041], and [0046] denoting the lenticle can replace cornea and be placed as a corneal onlay, inlay, or underlay), wherein said method comprises: providing at least one portion of said lenticule to comprise or to be coated by at least one material selected from the group consisting of collagen, collagen solution, collagen methacrylate, recombinant mammal collagen, collagen derivatives/fraction, collagen- like peptide(s), mammal-sourced collagen, and any combination thereof (see paragraph [0019] and [0041]); and, processing said at least one portion of said lenticule by a method selected from the group consisting of 3D printing, laser ablating, molding, and any combination thereof (see paragraphs [0012], [0013], [0016], [0019], [0041]).
Regarding Claim 24, Duan discloses the method of claim 23, additionally comprising at least one step selected from the group consisting of: cross-linking a collagen solution using 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS); dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; cross-linking a collagen solution using 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS); UV cross-linking said collagen solution; dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; UV cross-linking a collagen solution; dehydrating said collagen solution; and, cross- linking said dehydrated collagen solution with EDC and NHS; UV cross-linking said collagen solution; cross-linking a collagen solution using 1-ethyl- 3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS);dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; cross-linking said dehydrated collagen solution with EDC and NHS; dehydrating said collagen solution; and, UV cross-linking a collagen solution; and, any combination thereof (see paragraph [0016], [0042], and [0044]).
Regarding Claim 25, Duan discloses the method of claim 24, wherein said collagen solution comprises at least one substance selected from the group consisting of collagen, collagen methacrylate, human recombinant collagen, collagen derivatives/fraction collagen-like peptide(s), and any combination thereof (see paragraph [0019] and [0041]).
Regarding Claim 26, Duan discloses the method of claim 24, wherein said collagen solution is characterized by a collagen concentration, and said method additionally comprises increasing said collagen concentration (see paragraphs [0101] and [0102]).
Regarding Claim 27, Duan discloses the method of claim 24, wherein said dehydrating is performed by at least one lyophilizer (see paragraphs [0016], [0019], and [0042]).
Regarding Claim 29, Duan discloses the method of claim 24, additionally comprising: taking at least one action selected from the group consisting of 3D printing said collagen solution and molding said collagen solution (see paragraphs [0012], [0013], [0016], [0019], [0041]); and, crosslinking said collagen solution to form a transparent hydrogel (see paragraph [0016], [0042], and [0044]).
Regarding Claim 31, Duan discloses the method of claim 24, additionally comprising centrifuging said collagen solution (see paragraph [0016], [0019], and [0042]).
Regarding Claim 33, Duan discloses the method of claim 24, additionally comprising molding said collagen solution (see paragraphs [0012], [0013], [0016], [0019], [0041]).
Regarding Claim 35, Duan discloses the method of claim 24, wherein said step of cross-linking comprises cross-linking at a controlled temperature and humidity (see paragraphs [0043], [0073], and [0120]).
Regarding Claim 36, Duan discloses the method of claim 24, additionally comprising lyophilizing said intrastromal corneal lenticule graft prior to said step of cross-linking said collagen solution (see paragraphs [0016], [0019], and [0042]).
Regarding Claim 40, Duan discloses the method of claim 24, additionally comprising preparing a collagen solution configured to form a hydrogel characterized by a refractive index that is similar to that of native corneal stroma (see paragraph [0047]).
Claims 23 and 38-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060241751 A1 (hereafter –Marmo--).
Regarding Claim 23, Marmo discloses a method for the production of a rehydrated crosslinked intrastromal corneal lenticule graft for use at least one treatment selected from the group consisting of Keratoconus treatment and vision correction (see paragraph [0063]), said corneal lenticule graft configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0088]), wherein said method comprises: providing at least one portion of said lenticule to comprise or to be coated by at least one material selected from the group consisting of (see paragraphs [0074] and [0088]) collagen, collagen solution, collagen methacrylate, recombinant mammal collagen, collagen derivatives/fraction, collagen- like peptide(s), mammal-sourced collagen, and any combination thereof (see paragraph [0074]); and, processing said at least one portion of said lenticule by a method selected from the group consisting of 3D printing, laser ablating, molding, and any combination thereof (see paragraph [0088]).
Regarding Claim 38, Marmo discloses the method of claim 23, wherein said step of processing said at least one portion of said lenticule comprises molding, and said step of molding comprises molding by using a designated tool characterized by a predefined geometry and surface roughness (see paragraph [0088]).
Regarding Claim 39, Marmo discloses the method of claim 38, wherein said tool is made of a material selected from the group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof (see paragraph [0088] denoting that the mold could be made of ceramics, which is composite material).
Claims 23-24, 35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200046884 A1 (hereafter –Griffith--).
Regarding Claim 23, Griffith discloses a method for the production of a rehydrated crosslinked intrastromal corneal lenticule graft for use at least one treatment selected from the group consisting of Keratoconus treatment and vision correction (see paragraphs [0021] and [0091]) said corneal lenticule graft configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0075], [0218], and [0256]); wherein said method comprises: providing at least one portion of said lenticule to comprise or to be coated by at least one material selected from the group consisting of (see paragraph [0081]); collagen, collagen solution, collagen methacrylate, recombinant mammal collagen, collagen derivatives/fraction, collagen- like peptide(s), mammal-sourced collagen, and any combination thereof (see paragraph [0081]); and, processing said at least one portion of said lenticule by a method selected from the group consisting of 3D printing, laser ablating, molding, and any combination thereof (see paragraph [0027]).
Regarding Claim 24, Griffith discloses the method of claim 23, additionally comprising at least one step selected from the group consisting of: cross-linking a collagen solution using 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS); dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; cross-linking a collagen solution using 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS); UV cross-linking said collagen solution; dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; UV cross-linking a collagen solution; dehydrating said collagen solution; and, cross- linking said dehydrated collagen solution with EDC and NHS; UV cross-linking said collagen solution; cross-linking a collagen solution using 1-ethyl- 3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS);dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; cross-linking said dehydrated collagen solution with EDC and NHS; dehydrating said collagen solution; and, UV cross-linking a collagen solution; and, any combination thereof (see paragraphs [0016], [0120], and [0173]).
Regarding Claim 35, Griffith discloses the method of claim 24, wherein said step of cross-linking comprises cross-linking at a controlled temperature and humidity (see paragraphs [0173], [0164], [0180], and [0113]).
Regarding Claim 37, Griffith discloses the method of claim 24, wherein said step of cross-linking comprises performing said cross- linking in a controlled gas mixture environment other than air (see paragraphs [0173], [0164], [0180], and [0113]).
Claims 23-24, 28, 30, 32, 34, and 43-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200337830 A1 (hereafter –Peyman--).
Regarding Claim 23, Peyman discloses a method for the production of a rehydrated crosslinked intrastromal corneal lenticule graft for use at least one treatment selected from the group consisting of Keratoconus treatment and vision correction (see paragraphs [0127] and Abstract), said corneal lenticule graft configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0110] and Abstract), wherein said method comprises: providing at least one portion of said lenticule to comprise or to be coated by at least one material selected from the group consisting of collagen, collagen solution, collagen methacrylate, recombinant mammal collagen, collagen derivatives/fraction, collagen- like peptide(s), mammal-sourced collagen, and any combination thereof (see paragraphs [0150], [0153], and [0154]); and, processing said at least one portion of said lenticule by a method selected from the group consisting of 3D printing, laser ablating, molding, and any combination thereof (see Abstract and paragraph [0111-0114]).
Regarding Claim 24, Peyman discloses the method of claim 23, additionally comprising at least one step selected from the group consisting of: cross-linking a collagen solution using 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS); dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; cross-linking a collagen solution using 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS); UV cross-linking said collagen solution; dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; UV cross-linking a collagen solution; dehydrating said collagen solution; and, cross- linking said dehydrated collagen solution with EDC and NHS; UV cross-linking said collagen solution; cross-linking a collagen solution using 1-ethyl- 3-(3-dimethylaminopropyl) carbodiimide (EDC) and N-hydroxysuccinimide (NHS);dehydrating said collagen solution; and, cross-linking said dehydrated collagen solution with EDC and NHS; cross-linking said dehydrated collagen solution with EDC and NHS; dehydrating said collagen solution; and, UV cross-linking a collagen solution; and, any combination thereof (see paragraph [0107]).
Regarding Claim 28, Peyman discloses the method of claim 23, additionally comprising providing at least one portion of said lenticule to comprise or to be coated by cells selected from the group consisting of keratocytes, stem cells, and any combination thereof (see paragraphs [0110]).
Regarding Claim 30, Peyman discloses the method of claim 24, additionally comprising concentrating said collagen solution to a concentration of about 1% to about 15% w/v (see paragraphs [0203] and [0204]).
Regarding Claim 32, Peyman discloses the method of claim 24, additionally comprising 3D printing said collagen solution to a predefined shape (see Abstract, see also paragraphs [0109], [0157], and [0191]).
Regarding Claim 34, Peyman discloses the method of claim 24, wherein said step of cross-linking comprises: admixing photoinitiator to said collagen solution; and, applying light to said collagen solution after said step of admixing photoinitiator (see paragraph [0022], [0106]).
Regarding Claim 43, Peyman discloses the method of claim 23, additionally comprising ablating said lenticule to a predetermined shape and size by use of a laser system (see paragraph [0125] denoting that the lends may be shaped through ablation).
Regarding Claim 44, Peyman discloses the method of claim 43, comprising scanning said lenticule by an OCT (see paragraph [0204]), simultaneously to said step of ablating, hence forming a closed-loop feedback mechanism (see paragraph [0221]).
Regarding Claim 45, Peyman discloses the method of claim 43, wherein said laser system comprises an excimer laser and/or a femtosecond laser (see paragraphs [0125] and [0146]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over US 20140142200 A1 (hereafter --Duan--), in view of US 7476398 B1 (hereafter –Doillon--).
Regarding Claim 41, Duan discloses the method of claim 23.
Duan fails to disclose wherein at least one of the following is true: said solution is configured to form a hydrogel characterized by elastic modulus ranging between about 50 kPa to about 13 MPa; said solution is configured to form a hydrogel characterized by permeability to glucose, oxygen and proteins each of which is at least 50% of permeability of native corneal stroma tissue to glucose, oxygen, and proteins, respectively; and, said solution is configured to form a hydrogel which at least partially blocks UV light.
Doillon discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see Abstract, see also claim 1), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see column 5, lines 14-18, see also column 5, lines 30-40, see also ); wherein said method comprising steps of a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see column 5, lines 41-59) and, b. processing the lenticule graft by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see column 4, lines 12-15, see also column 7, lines 50-53, see also column 9, lines 22-31). Doillon teaches wherein at least one of the following is held true: a. said solution is configured to form a hydrogel characterized by elastic modulus ranging between about 50kPA to about 13MPa (see column 3, lines 33-40). [b. said solution is configured to form a hydrogel characterized with permeability to glucose, oxygen and proteins which is at least about 50% of the permeability of native corneal stroma tissue; c. said solution is configured to form a hydrogel which at least partially blocks UV light.]
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the solution of Duan to be configured to form a hydrogel characterized by elastic modulus ranging between about 50kPA to about 13MPa, since it has been held to be within the general skill of a worker in the art to select a known material (and therefore material stiffness (elastic modulus)) on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over US 20140142200 A1 (hereafter --Duan--), as applied to claim 29 above, in view of US 20190307551 A1 (hereafter --Peyman #2--).
Regarding Claim 45, Duan discloses the method of claim 29.
Duan fails to disclose additionally comprising marking said transparent crosslinked hydrogel for a correct orientation by using at least one member of the group consisting of a laser engraver, a mechanical press, ink, and any combination thereof.
Peyman #2 discloses a corneal implant and method of preparing said implant (see Abstract). Peyman #2 teaches additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one member of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof (see paragraph [0568]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Peyman to further additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one or more members of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof, as by doing so would promote ease of implantation (see paragraph [0568]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130209571 A1: This reference discloses removing cells prior to graftation of a graft implant.
US 20190307551 A1: This reference discloses an eye implant that can be formed from epithelial stem cells extracted from a human.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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